Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies; Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria

• Disability equivalent to an EDSS of 6.0 or less at screening

• Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be from before screening

• previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment

• A priori has been decided to be treated with AVONEX

Exclusion Criteria:

• Is NAb positive on AVONEX

• History of major depression

• Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg)

• Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit

• Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability

• Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives